Additional Information

Selecting Foreign Food Facilities for Inspection

Why is FDA increasing surveillance of imported food products?

The U.S. Food and Drug Administration (FDA) has increased the number of routine inspections of all food facilities to meet new requirements mandated by the FDA Food Safety Modernization Act (FSMA), which was signed into law by the President on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Under FSMA, FDA will continue its practice of selecting facilities for inspection based on risk. FSMA required FDA to immediately increase inspections of both foreign and domestic food facilities, including manufacturers/processors, packers, repackers, and holders of foods under FDA jurisdiction, and mandated an inspection frequency, based on risk, for food facilities. All high-risk domestic facilities must be inspected within five years of enactment and at least once every three years after that. Within one year of enactment, the law directed FDA to inspect at least 600 foreign facilities and to double those inspections every year for the next five years.

FDA’s foreign surveillance inspections are designed to identify potential food safety problems before products arrive in the United States, to determine the compliance status of facilities with FDA’s requirements and food safety standards, to help the agency make admissibility decisions when food products are offered for importation into the United States, and to help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.

These routine inspections are not conducted as part of a public health emergency, but are an important way for FDA to ensure that foreign food facilities exporting to the U.S., and their products, meet U.S. requirements. It is important to note that routine inspections are designed to evaluate a facility’s adherence to applicable U.S. laws and are not designed to assess a Competent Authority’s food safety system. As such, these inspections are different from systems audits.

What criteria does FDA use for selecting foreign food facilities for inspection?

FDA’s selection of foreign food facilities for inspection is based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include the following: (1) the food safety risk associated with the commodity (the type of food), (2) the manufacturing process, and (3) the compliance history of the facility, such as refusal rates for products that were denied entry into the United States. In addition, section 201 of FSMA requires FDA to identify high-risk facilities and allocate resources to inspect facilities according to the known safety risks, and includes several other factors to consider when developing a facility’s risk profile.

Please visit the FSMA Domestic Facility website for information on how FDA currently identifies a high risk food facility in the domestic arena. FDA is working on a similar risk categorization scheme, as developed for the selection of domestic facilities, to further describe the selection of foreign food facilities for inspection. It will be added to this website when completed.

What is FDA’s focus while conducting a routine surveillance inspection?

The purpose of an FDA inspection is to determine a facility’s compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulations (CFR), including, when applicable, Part 110 (Current Good Manufacturing Practices (GMP) in Manufacturing, Packing, or Holding Human Food) and any other U.S. regulations applicable to the specific type of food produced. For instance, canned foods will be inspected for compliance with the low-acid canned or acidified food regulations in 21 CFR Parts 113 and 114. Dietary supplements will be inspected for compliance with good manufacturing practices for dietary supplements, 21 CFR Part 111. A single inspection may focus on multiple requirements, such as a canned tuna product that may be inspected for compliance with seafood hazard analysis and critical control point (HACCP) systems, canning regulations, labeling requirements and current GMPs.

Please note that these are routine inspections of individual facilities designed to evaluate a facility’s adherence with applicable U.S. laws and are NOT system audit visits designed to evaluate a country’s Competent Authority food safety system.

Communications with Foreign Embassies and Competent Authorities

Does FDA notify foreign Embassies and Competent Authorities of the countries where food facilities have been selected for inspection?

Yes. FDA’s Center for Food Safety and Applied Nutrition sends an advance notification to the Competent Authority responsible for food safety in the country where FDA will be conducting an inspection. FDA’s Center for Food Safety and Applied Nutrition makes every effort to notify each corresponding competent authority. In some cases, FDA is unable to reach the proper competent authority in advance. FDA always welcomes competent authorities to share their contact information with the agency. Please see questions number 8 & 36 for information on how you could share such information with FDA.

When contacting a Competent Authority, FDA copies their Embassy.

Does FDA notify the Competent Authority when FDA notifies a facility in that country of FDA’s intent to conduct an inspection?

Yes. The Competent Authority receives a copy of this notification. Once an inspection is planned, the final itinerary is shared with the Competent Authority as well.

Does FDA invite Competent Authorities to participate in these inspections?

Do FDA Investigators meet with the Competent Authority while in-country to discuss the inspection?

FDA Investigators are fact finders and are not in the best position to discuss policy matters. In addition, FDA Investigators are assigned regulatory inspections on a very tight schedule while in your country and their schedules do not provide sufficient time to travel to the Competent Authority’s headquarters to participate in policy meetings. The Competent Authority is always welcome to accompany FDA during inspections and to observe the opening and close-out meeting that FDA holds with the facility’s management and in this way they can hear first-hand the purpose and scope of the inspection, the relevant program guidance for the inspection, and the inspection observations.

How can an Embassy or Competent Authority obtain a copy of a FDA-483 or Establishment Inspection Report?

Before an Inspection- Communications with the Food Facility

Does FDA notify a foreign food facility that it has been selected for inspection?

Yes. FDA contacts each food facility by sending a letter via email, fax, and/or postal mail. FDA obtains the facility’s contact information from FDA’s Food Facility Registration database. Food facilities are required to maintain current contact information with FDA as part of the registration of food facilities regulations in 21 CFR Part 1, subpart H. The competent authority is also notified.

Does FDA provide food facilities with a checklist indicating what will be covered during an inspection?

Generally, FDA does not provide checklists for its food inspections. However, for low-acid canned foods, facilities can use the LACF/AF Inspection Forms, FDA 3511 series, to conduct self-audits of their canning facility and specific processing systems. These forms can be found on FDA’s web site at About FDA - FDA Forms.

For additional information on FDA’s requirements and inspectional procedures please see the following:

Are the letters that FDA sends to foreign food facilities notifying them of FDA’s intent to conduct an inspection written both in English and the official language of the foreign country?

The initial notification of inspection to the facility from FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is transmitted in English and the official language (s) of the country. Any further communication with the food facilities regarding an upcoming inspection, including scheduling dates and visit logistics, are conducted in English. In addition, any regulatory correspondence, such as violation letters (i.e., Warning or Untitled Letters), is issued only in English.

What if I am a broker or exporter of foods and I am contacted by FDA for an inspection?

FDA does not inspect foreign brokers and exporters of foods, but we sometimes contact them in the course of planning an inspection and we would appreciate your assistance in identifying your suppliers.

What happens after FDA notifies a food facility that FDA intends to inspect their facility?

First, the facility should acknowledge FDA’s notification of inspection. After the facility acknowledges FDA’s intent to inspect their facility, FDA contacts the facility again by letter with specific information regarding the proposed inspection dates, and logistical information, including the availability of interpreter assistance; full mailing and physical address of manufacturing, processing, packing, or holding facility; and the contact information of responsible person or persons. The competent authority receives a copy of this notification. Once the inspection is planned with the food facility, the final itinerary is shared with the competent authority.

If a food facility fails to respond to FDA’s notice of inspection, the facility’s product or products may be refused entry into the United States.

Refusal to Permit Inspection

What happens if a foreign food facility or foreign Government refuses to permit FDA to conduct an inspection?

Section 306 of the FDA Food Safety Modernization Act (FSMA) amended the Federal Food, Drug and Cosmetic Act, under Section 807 (b), by, among other things, directing FDA to refuse admission of food into the U.S. when that food is from a foreign factory, warehouse or other establishment that refuses to allow inspection.

When FDA is not permitted to conduct an inspection, FDA will consider all of its regulatory options in determining whether such products are subject to refusal of admission into U.S. commerce. FDA action may include: placing the facility on import alert; increasing sampling and/or examination; refusal of admission; or other regulatory, judicial and administrative measures. FDA may consider a facility’s failure to respond to FDA’s notice of intent to conduct an inspection as a refusal. Thus, failure to respond to FDA’s notice of inspection may result in an import alert, the facility’s product or products may be refused entry into the United States.

For additional information on FDA’s new authority under FSMA to refuse entry to the U.S. of imported foods due to an inspection refusal please visit:

During an Inspection

Is an FDA food inspection the same as a food safety system’s audit?

Routine inspections are not conducted as part of a public health emergency, but are an important way for FDA to ensure that foreign food facilities exporting to the U.S., and their products, meet U.S. requirements. It is important to note that routine inspections are designed to evaluate a facility’s adherence to applicable U.S. laws and are not designed to assess a Competent Authority’s food safety system. As such, these inspections are different from systems audits.

How much time does FDA spend in each country to conduct inspections?

FDA may schedule multiple inspection trips in a particular country throughout the year. Trips are generally two to three weeks in duration.

How many food facilities does FDA plan to inspect in each country during a three-week period?

An inspection trip may include four or more food facilities in a two to three week period.

How long should it take FDA to complete each food facility inspection?

Most inspections of foreign food facilities take one to three days to complete, depending on the focus of the inspection and the conditions observed, among other things.

Does FDA visit a country more than once to conduct its food facility inspections?

A country may be visited by FDA at different times throughout the year in order to complete all planned inspections.

Will FDA discuss inspectional observations while the inspection is being conducted?

Yes. It is FDA’s practice for FDA investigators and analysts to discuss observations with the person in charge at the establishment while the inspection is being conducted, as appropriate, and at the end of the inspection during the closeout meeting. This practice ensures that inspected facilities have an opportunity to discuss the investigator’s observations before the investigator issues the Inspectional Observations form, FDA-483, if one is issued.

If an establishment makes corrections during the course of an inspection, will FDA verify the corrections?

Yes, FDA investigators will verify any completed corrective actions so long as the verification does not unreasonably extend the duration of the inspection. FDA also may verify corrective actions through communications with the facility, by conducting examinations or sampling at ports of entry, by conducting a compliance follow-up inspection, or any combination of these.

After an Inspection

What does an FDA investigator do upon completing an inspection?

If significant problems are identified during the inspection, FDA issues an FDA-483 (Inspectional Observations form) to the company’s management at the inspection close-out meeting. Facilities may use this meeting to request clarification, to demonstrate to the FDA inspection team any corrections that were implemented during the inspection, and to explain any corrections the facility intends to make at a later time. After completing a foreign inspection, the investigator completes a written narrative of the inspection, known as an Establishment Inspection Report.

As appropriate, FDA may take official action based on the inspectional findings, including subjecting the facility and its products to an Import Alert, issuing violation letters, or other activities. If the inspection verifies that the facility is in compliance with FDA’s requirements and food safety standards, a copy of the narrative Establishment Inspection Report is sent to the facility. If significant problems are identified, FDA will provide a copy of the narrative report to the facility’s management after violations are resolved or after FDA has taken any necessary regulatory action. For additional information on FDA’s requirements and inspectional procedures please see the following:

Should a facility respond in writing to FDA after receiving a FDA-483, Inspectional Observations form?

Yes. At the inspection close-out meeting, the FDA investigator will provide instructions to the facility about how to respond in writing to FDA. The facility’s submission should include a letter explaining all corrective actions taken by the facility that were not implemented and verified by the investigator during the inspection. In addition, the facility’s response should include supporting documentation, which may include records of repair, implementation of new monitoring activities, pictures, revised HACCP plans, or any other information that may be necessary to demonstrate that appropriate corrective action has been completed. Please refer to the following weblink for additional information on how FDA conducts close-out meetings with a facility’s management.

Facilities are encouraged to submit their responses to a FDA-483, along with supporting documentation, within 15 business days after the close-out meeting. Please see following website for additional information about facilities responses to FDA-483:

Discussions With Management

Procedures

FDA encourages facilities to submit responses in Acrobat-PDF format to the following email account: FDA483responseinternational@fda.hhs.gov. FDA will send a confirmatory email in return to acknowledge receipt.

If electronic submission is not possible, a hardcopy package may be mailed to the following postal address:

Foreign inspections are designed to identify potential food safety problems before products arrive in the United States. FDA investigators provide initial notification about significant deviations from U.S. requirements by sharing their observations with the inspected facility throughout and at the conclusion of the inspection. This exchange of information facilitates corrections. These inspection findings are used by FDA's import operations to construct a risk profile for commodities produced by inspected facilities. FDA adjusts its import measures, including may proceed rates, examination and sampling frequency, based on these risk profiles.

Food Facility Biennial Registration Renewal

When does a facility need to start biennial registration renewal if it is required to register with FDA under FDCA §415

FSMA amended FDCA §415 to provide that facilities required to register will have to renew their registration every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years, beginning in 2012. For additional information on FSMA’s biennial registration renewal provision please visit:

FDA plans to issue additional information on how food facilities can renew their registrations and the information that will be needed to complete the registration renewal process. Food Facilities will be encouraged to renew their registrations electronically.

Must a foreign facility have a U.S. agent?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires a foreign facility registration to include a U.S. agent. Foreign facilities must designate a U.S. agent who lives or maintains a place of business in the U.S. and is physically present in the U.S. for purposes of registration. The U.S. agent may be authorized to register the facility.

The U.S. agent:

FDA does not require a food facility to use a third-party registrar to submit an initial registration, update, renewal, or cancellation of a food facility registration to FDA.

Please visit the following websites for additional information on U.S. agent requirements, including information on third-party registrar:

Can be any person that resides or maintains a place of business in the United States and is physically present in the United States

Communicates with FDA on behalf of the foreign facility in both routine and emergency circumstances

Will be contacted by FDA if an emergency occurs, unless the foreign facility opts to designate a different emergency contact

Re-inspection Fees

Will my food facility be billed for a routine inspection?

No. There is no fee for a routine FDA inspection.

Will my food facility be billed for a reinspection?

Section 107 of FSMA authorizes FDA to assess and collect fees related to reinspections of certain domestic food facilities, foreign food facilities, and importers. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems. This fee may be assessed if FDA conducts a reinspection to evaluate corrective actions following a previous FDA inspection of the same facility that was classified Official Action Indicated (OAI) and FDA determined the non-compliance was materially related to a food safety requirement.

For facility reinspection fees, FDA will invoice the responsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For information on rates and additional information on these fees please visit:

A compliance follow-up inspection is conducted, in most cases, to verify that a facility has implemented appropriate corrective actions to address violations observed during an initial inspection; this type of compliance follow-up inspection is considered a reinspection and subject to fees (please refer to previous question for additional information on these fees).

A compliance follow-up inspection can also be conducted to investigate information received as part of a reportable food registry submission, recall investigation, outbreak investigation, or to investigate information collected during import entry reviews, including examinations and samples, but these types of compliance follow-up inspections are not subject to fees, initially.

Publicly Available Inspection Results

What is FDA’s Compliance Transparency Initiative?

In response to the President’s commitment to openness in government, FDA launched the Transparency Initiative in June 2009. Under this initiative, FDA has taken steps to make FDA’s enforcement activities more transparent. For example, FDA has posted online a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification, as well as a summary of the most common inspectional observations.

Yes. If a member of the public, including persons and companies in the U.S. and abroad, files a request under the Freedom of Information Act (FOIA) for a FDA-483, FDA first will remove any protected information from the document (for example, trade secret or confidential commercial information), and then release this redacted document to the requester. FDA redacts and makes available Establishment Inspection Reports to persons or companies filing a FOIA request only after FDA officially closes the inspection assignment. Please refer to the following website for information on the FOIA process.

FDA is proactively making records of domestic and foreign inspections publically available at the agency’s discretion or from frequently requested records through the FOIA process; this includes FDA Form 483, Establishment Inspection Reports and Warning Letters. For additional information on publically available inspection records please visit: ORA FOIA Electronic Reading Room.

Under U.S. law, FDA is not always authorized to share inspection reports with competent authorities, but the facility may choose to share this information with other entities outside the facility, including the competent authority/government and/or trade associations.

How does FDA protect a facility’s trade secret and confidential commercial information?